Talazoparib

What is Talazoparib?

• Talazoparib (Talzenna) is a poly (ADP-ribose) polymerase (PARP) inhibitor used for the treatment of germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.

Talazoparib

What are the uses of this medicine?

Talazoparib (Talzenna) is used to treat adults with:

• a certain type of breast cancer (human epidermal growth factor receptor 2 [HER2]-negative), and
• an abnormal inherited BRCA gene, and
• whose cancer has spread to other parts of the body (locally advanced or metastatic).

How does this medicine work?

• Talazoparib (tal" a zoe' pa rib) is a potent small molecule inhibitor of polyadenosine 5’-diphosphoribose (ADP-ribose) polymerase (PARP), an enzyme involved in repair of single strand breaks in DNA and which is used in the therapy of breast cancer.
• In normal cells, DNA repair mechanisms include base excision repair for single strand DNA breaks, for which PARP plays an important role, and homologous recombination for double-strand DNA breaks for which the tumor suppressor proteins BRCA-1 and BRCA-2 are involved.
• In patients with cancers associated with BRCA mutations, and particularly those with breast and ovarian cancer, the cancer cells are particularly susceptible to PARP inhibitors which cause accumulation of DNA breaks and resultant cell necrosis.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Be sure to mention any of the following:
• amiodarone (Cordarone, Pacerone), carvedilol (Coreg), clarithromycin (Biaxin, in Prevpac), itraconazole (Onmel, Sporanox), sulfasalazine (Azulfidine), and verapamil (Calan, Covera, Isoptin, Tarka, Verelan).

Is this medicine FDA approved?

• Talazoparib was approved for therapy of breast cancer (HER negative, BRCA positive) in the United States in 2018.

How should this medicine be used?

Recommended dosage:

• The recommended dose of Talzenna is 1 mg taken as a single oral daily dose, with or without food.
• For adverse reactions, consider dosing interruption or dose reduction.
• For patients with moderate renal impairment (CLcr 30 – 59 mL/min), the recommended dose of Talzenna is 0.75 mg once daily.
• For patients with severe renal impairment (Clcr 15 – 29 mL/min), the recommended dose of Talzenna is 0.5 mg once daily.

Administration:

• Take Talzenna 1 time a day.
• Take Talzenna with or without food.
• Swallow Talzenna capsules whole.
• Do not dissolve or open Talzenna capsules.
• If you miss a dose of Talzenna or vomit, take your next dose at your regular time.
• Do not take an extra dose to make up for a missed dose.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg

This medicine is available in fallowing brand namesː

• Talzenna

What side effects can this medication cause?

The most common side effects of this medicine include:

• tiredness or weakness
• low number of red or white blood cells
• nausea
• low number of platelets
• headache
• loss of appetite
• diarrhea
• vomiting
• hair loss

Talzenna may cause serious side effects, including:

• Bone marrow problems
• myelodysplastic syndromes
• marked myelosuppression
• embryo-fetal toxicity

What special precautions should I follow?

• Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) have been reported in patients who received Talzenna. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed.
• Myelosuppression consisting of anemia, leukopenia/neutropenia, and/or thrombocytopenia, have been reported in patients treated with Talzenna. Talzenna may affect hematopoiesis and can cause anemia, neutropenia, and/or thrombocytopenia. Monitor complete blood count for cytopenia at baseline and monthly thereafter.
• Based on its mechanism of action and findings from animal data, Talzenna can cause fetal harm when administered to a pregnant woman. Advise of the potential risk to the fetus and to use effective contraception.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Symptoms of overdose have not been established.

Management of overdosage:

• There is no specific treatment in the event of Talzenna overdose.
• In the event of overdose, discontinue treatment with Talzenna, consider gastric decontamination, follow general supportive measures, and treat symptomatically.

Can this medicine be used in pregnancy?

• Based on findings from animal studies and its mechanism of action, Talzenna can cause embryo-fetal harm when administered to a pregnant woman.
• There are no available data on Talzenna use in pregnant women to inform a drug-associated risk.

Can this medicine be used in children?

• The safety and effectiveness of Talzenna have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: talazoparib tosylate
• Inactive ingredients: silicified microcrystalline cellulose (sMCC). The capsule shells contain hypromellose (HPMC), yellow iron oxide, red iron oxide and titanium dioxide. The printing ink contains shellac, black iron oxide, potassium hydroxide, ammonium hydroxide, and propylene glycol.

Who manufactures and distributes this medicine?

Packager: Pfizer Laboratories Div Pfizer Inc.

What should I know about storage and disposal of this medication?

• Store Talzenna at 68°F to 77°F (20°C to 25°C ).

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• Dailymed label info on Talazoparib
• FDA Talazoparib